Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxcarbazepine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| % change in seizure frequency/24 hours; change in seizure frequency/24 hours; response to treatment (at least a 50%, 75%, or 100% reduction seizure frequency/24 hours). |
Not provided
INCLUSION CRITERIA: To enter this study, patients must:
EXCLUSION CRITERIA: To enter this study, a patient must not have or be:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
| Mobile |
| Alabama |
| 36693 |
| United States |
| Los Angeles | California | 90027 | United States |
| Los Angeles | California | 90095 | United States |
| Madera | California | 93638 | United States |
| Orange | California | 92868 | United States |
| Wilmington | Delaware | 19806 | United States |
| Miami | Florida | 33155 | United States |
| Tampa | Florida | 33607 | United States |
| Atlanta | Georgia | 30342 | United States |
| Boise | Idaho | 83712 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Duluth | Minnesota | 55805 | United States |
| Saint Paul | Minnesota | 55102 | United States |
| Chesterfields | Missouri | 63017 | United States |
| Buffalo | New York | 14222 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10032 | United States |
| Akron | Ohio | 44308 | United States |
| Cincinnati | Ohio | 45229 | United States |
| Cleveland | Ohio | 44106 | United States |
| Portland | Oregon | 97201 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Fort Worth | Texas | 76104 | United States |
| Houston | Texas | 77030 | United States |
| Norfolk | Virginia | 23507 | United States |
| Brigadeiro Hospital | Sao Paulo - SP | 01401-901 | Brazil |
| Kehl-Kork | 77694 | Germany |
| Kiel | 24105 | Germany |
| Novartis | Mexico City | Mexico |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D004828 | Epilepsies, Partial |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078330 | Oxcarbazepine |
| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided